Policy Title / Informed Consent

Policy

Respect for persons requires thatresearch participants and/or their legally authorized representative (referred to together as participant), be given the opportunity to choose what will or will not happen to them (Belmont Report). Participants must be provided information about the nature of the research and based on comprehension of that information, voluntarily decide whether or not to participate.

Consent must be obtained face to face unless another process is approved by the IRB. Consent must be obtained under circumstances that provide the prospective participant sufficient opportunity to carefully consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the prospective participant must be in a language understandable to the participant and may not include any language which waives or appears to waive any of the participant’s legal rights or releases or appears to release the parties to the research from liability for negligence.

Investigators or delegated personnel must obtain written informed consent from the participant and/or LAR. The IRB may waive this requirement under DHHS regulations governing human subject research (46.116(c)), but may not waive consent for studies regulated by the FDA unless the subject is in a life-threatening condition and criteria under 21 CFR 50.23 or 50.24 are met.

If the participant is an adult who is unable to consent for him/herself, the investigator must describe in the IRB application the process of evaluation the individual’s capacity to provide consent, and if that capacity is lacking, must obtain informed consent from a legally authorized representative in accordance with State law.

See “Review of Clinical Investigations Involving Children” for assent and parental permission policy.

Nothing in these regulations is intended to limit the authority of a physician to provide emergency medical care to the extent the physician is permitted to do so under applicable Federal, State or local law.

Definitions

Informed consent – an ongoing educational process that takes place between the investigator, designated research staff and the participant, allowing for the exchange of information the opportunity to answer questions throughout the course of the study.

Legally Authorized Representative (LAR) - an individual who has the authority under applicable State or local law to make research participation decisions on behalf of another. In accord with state law, individuals who can serve as legally authorized representatives are as follows, in order, according to RCW 7.70.065:

  1. The appointed guardian of the patient, if any;
  2. The individual, if any, to whom the patient has given durable power of attorney that encompasses the authority to make healthcare decisions;
  3. The patient’s spouse or STATE REGISTERED DOMESTIC PARTNER
  4. Children of the patient who are at least 18 years of age
  5. Parents of the patient, and
  6. Adult brothers and sisters of the patient

Procedures

Informed Consent Process and Documentation -

  1. The PI submits a proposed informed consent procedure and written document with his/her IRB application prior to initiation of the research. The IRB application must identify study personnel who are delegated to obtain informed consent. See Informed Consent Template and Guidelines on website.
  1. At a minimum, the proposed consent process and form must include the following ninefederally required elements:
  1. Research statement - a statement that the study involves research, an explanation of the purpose of the research, an explanation of the expected duration of participation, a description of the procedures involved, and identification of any procedure(s) which are experimental;
  2. Reasonably foreseeable risks or discomforts - a statement that describes foreseeable risks or discomforts associated with the research, the likelihood of their occurrence and the ramifications associated with the risks (for example; decreased blood counts may result in the need for a blood transfusion);
  3. Reasonably expected benefits to subjects and/or others – a statement that describes benefits to subjects and/or others that may reasonably be expected from the research including no benefit, if this is applicable. Payment for participation in a research project is not considered a benefit.
  4. Appropriate alternatives – a statement that describes with enough detail any alternative procedures or course of treatment that may benefit the subject, including the same treatment outside the study if applicable. If no alternatives exist, the consent form must state that there are no alternatives except not to participate.
  5. Extent of Confidentiality – a statement that describes the extent to which the investigator/study personnel will maintain or not maintain confidentiality of records identifying the subject (for example; law requires reporting of child abuse, etc) and describes how the research team will protect the subject’s private records during and after the conclusion of the proposed research. Any research that is subject to audit or inspection must identify who will have access to the subject’s records (for example: the study sponsor, FDA, NIH, facility where procedure took place, IRB-Spokane).
  6. Compensation for treatment related injury – for studies with greater than minimal risk, a statement explaining any compensation and an explanation of any medical treatments available if injury occurs. Information about where the subject may obtain further information.
  7. Contact information – a statement that describes contact information details including telephone numbers, and whom to contact for the following situations:
  8. questions about the subject’s illness, treatment or research – investigator
  9. questions about research related injury - investigator
  10. questions about the subject’s research rights, comments, or complaints - IRB
  11. Voluntary participation - a statement that describes clearly that participation in the research is voluntary and refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled. The subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
  12. Reference to ClinicalTrials.gov – the following language must appear in the confidentiality section verbatim – “A description of this clinical trial will be available on as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.”
  1. Where appropriate the following additional elements must be included –
  1. Unforeseeable risks to subjects, embryos or fetuses–a statement warning subjects that some risks are currently not known or foreseeable
  2. Investigator termination of participation – a statement that describes the instances in which an investigator or the study sponsor may terminate a subject’s participation (for example: non-compliance, treatment not in subjects best interest)
  3. Additional costs - a statement that describes any additional costs to the subject from participation in the study (for example: research only procedures that may not be covered by the participants insurance, transportation, time away from work, parking)
  4. Early withdrawal/procedures for termination – a statement that describes the consequences of a subject’s decision to withdraw from the study and procedures for orderly termination from participation for the subject’s safety
  5. Significant new findings – a statement that subjects will be told of any new findings which may affect their willingness to remain in the study
  6. Approximate number of subjects – a statement that explains the approximate number of subjects to be in the study; both nation/worldwide and locally
  1. The following additional information is required as appropriate:
  2. Payment or stipends paid to subjects for participation or travel reimbursement
  3. Disclosure of any conflict of interest of research team members
  4. HIPAA authorization
  1. In order for the consent to be informed, investigators or delegated research staff are responsible for determining that the research participant has comprehended the information presented. Methods for ascertaining comprehension vary and take into account the participants circumstances and abilities (for example: maturity, intelligence, language skills). Possible methods including asking questions to determine comprehension of key points, reviewing key points that are known to be difficult for participants to comprehend.
  1. The IRB will take into consideration, when relevant, timing issues when approaching prospective participants regarding participation in the research project. Timing considerations must be weighted carefully in situations that increase the vulnerability of research participants. Examples include newly diagnosed patients, patients diagnosed with a terminal illness, patients in a critical care or emergency situation or parents, siblings or other family members of a recently deceased family member.
  1. If the research involves vulnerable populations or sensitive issues, the investigator must address additional regulatory and/or institutional requirements. Vulnerable populations and sensitive issues include but are not limited to:
  1. Research involving children
  2. Research involving pregnant women
  3. Research involving individuals with handicaps or impaired consent capacity
  4. Research involving HIV screening and/or AIDS research
  5. Research involving DNA banking, genetic research, or gene therapy
  6. Research involving prisoners (this IRB does not review prisoner research)
  1. Upon approval an “IRB approval stamp” will be added to the document. Approval for the consent document will last the life of the study, or until it is modified – whichever comes first. Only copies of IRB approved documents may be presented to participants.
  1. Subjects that are transferring between research sites must be re-consented using the current local IRB approved consent.
  1. Signatures must be obtained as follows:
  2. Participant, or participants LAR - sign, date and time
  3. Person obtaining informed consent – sign and date.
  4. A witness signature will be required only in the case of a person who cannot read the informed consent (for example a blind person, or a person unable to read) and must have it read to them or in specific cases as required by the federal regulations. See Informed Consent Template and Guidelines.
  1. The participant must receive a copy of the signed informed consent document.

Consent of LAR by Telephone–

  1. In certain situations the IRB may allow an LAR to consent by telephone if he/she cannot be present.
  1. The PI or designee should first contact the LAR to obtain, via facsimile or scanned e-mail, documents such as health care power of attorney or a copy of the court document appointing the LAR as legal guardian and personal identification.
  1. Once the identifying documents are received, the informed consent (IC)document must be faxed to the LAR prior to the consent discussion.
  1. The PI or designee must review the IC and conduct a complete consent discussion with the LAR over the telephone.
  1. An independent witness, an individual not employed by the research site, must participate in the telephone call to attest to the understanding of the LAR.
  1. The LAR must sign the IC and fax or scanned e-mail it back to the site. A signed copy of the IC should be faxed by to the LAR.
  1. The person conducting the consent discussion and the independent witness must sign the IC and document that the discussion occurred via telephone.

Use of the Short Form Written Consent Document -

  1. The PI may request to use a short form written consent document stating that study personnel will present the elements of informed consent orally to the subject or the subject’s LAR. This format is not commonly approved by the IRB.
  1. The IRB reviews the request and may approve the short form option for documentation only if the study meets all of the requirements as outlined in 45 CFR 46.117(b) and 21 CFR 50.27(b).
  1. When the IRB approves use of the short form method –
  2. There must be a witness to the oral presentation. For participants who do not speak English, the PI must ensure the witness is conversant in both English and the language of the participant.
  3. The IRB must approve a written summary of the oral consent presented to the participant, which embodies the basic and appropriate elements of disclosure
  4. The participant signs, with date/time, the short form
  5. The witness signs and dates both the short form and the summary
  6. The person actually obtaining consent signs and dates the summary
  7. The person obtaining consent gives a copy of the summary and a copy of the short form to the participant.

Wards –

Per 21 CFR 50.56 and/or 45 CFR 46.409 - Children who are wards of the State or any other agency, institute or entity can be included in clinical investigations approved under 21 CFR 50.53 or 50.54 only if such clinical investigations are:

  1. Related to their status as ward; or
  2. Conducted in schools, camps, hospitals, institutions or similar settings in which the majority of children involved as subjects are not wards.
  3. If the clinical investigation is approved as described above, the IRB must require appointment of an advocate for each child who is a ward
  4. The advocate will serve in addition to any other individual acting on behalf of the child as guardian or in loco parentis (power of attorney)
  5. One individual may serve as advocate for more than one child
  6. The advocate must be an individual who has the background and experience to act in, and agrees to act in, the best interest of the child for the duration of the child’s participation in the clinical investigation
  7. The advocate must not be associated in any way (except in the role as advocate or member of the IRB) with the clinical investigation, the investigator(s), or the guardian organization.

Emancipated Minor –

A minor who obtains a court order declaring emancipation may give consent. Absent a court order, there is no clear definition of an “emancipated” minor.

Age of Majority–

When consent is given for a minor child to participate in a research study by one or both parents, and the child reaches the age of majority (18 years) the child must be re-consented as an adult to continue participation in the study.

  1. If age of majority is reached while the participant is receiving study interventions per the study protocol, he/she must be re-consented using the most current approved IRB informed consent document.
  1. If age of majority is reached after all study interventions have been completed and the participant remains in the study for purposes of data collection for outcomes only, a separate “Age of Majority” informed consent must be obtained and a copy of the original informed consent given to the participant.

Research that Requires Monitoring of Informed Consent/Assent Process and Procedures –

  1. The IRB determines when research requires monitoring of the informed consent/assent process and the procedure and frequency with which such monitoring will occur based on the degree of risk to the subject, the need for protection of vulnerable subjects, or concerns related to an incident of non-compliance.
  1. An IRB Co-Chair, delegatedIRB staff or other IRB member designee (as determined by an IRB Co-Chair) may monitor the informed consent/assent process. The monitoring may involve direct observation, interviews of subjects, surveys of subjects, or other means as deemed appropriate by the IRB for the circumstances.

Recordkeeping –

  1. The PI or designated staff places a copy of the signed consent form and, if applicable, the Assent and/or HIPAA Addendum in the subject’s medical record. The PI must keep the original copy of the signed consent and, if applicable, the Assent and/or HIPAA Addendum in accordance with Federal regulations.

Waiver or Alteration of Informed Consent or Documentation of Informed Consent–

  1. 21 CFR 56.109(c)(1)(2) – The IRB may for some or all subjects, waive the requirement that the subject, or the subject’s LAR, sign a written consent if it finds:
  2. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context, or;
  3. Finds that the requirements § 50.24 for an exception from informed consent for emergency research are met.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

  1. 45 CFR 46.117(c) –The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

a.That the onlyrecord linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality.Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; or

b.The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

Research Data Retention –

  1. When a subject withdraws from a study, the data collected on the subject to the point of withdrawal remains part of the study database and may not be removed. The consent document cannot give the subject the option of having data removed.
  1. If a subject expresses a desire to withdraw from the study, the level of continued participation must be documented by the PI. This could range from data collection from standard of care visits for outcomes, medical record review, phone/electronic communications to total withdrawal of consent.
  1. If a subject withdraws consent the PI must not access for purposes related to the study the subject’s medical record or other confidential records requiring the subject’s consent. However, an investigator may review study data related to the subject collected prior to the subject’s withdrawal from the study, and may consult public records, such as those establishing survival status.

Re-Consenting–

  1. Research is an on-going process which involves the constant re-evaluation of current information and procedures. PI’s are ethically obligated to keep subjects informed of all issues related to their participation in the study. New information regarding their willingness to continue in the study must be presented to research subjects as a written Addendum to the Informed Consent or revised Informed Consent document. Actively participating subjects must sign the Addendum to the Informed Consent, or a revised Informed Consent document to continue participating in the study. Occasionally, new information can be given to the subject via a letter with approval by the IRB.
  1. Federal regulations to not require re-consenting of subjects who have completed their active participation in the study, or of subjects who are still actively participating, when the proposed change will not affect their participation.
  1. The IRB requires review and approval prior to a PI providing subjects with any new research information, except where necessary to eliminate apparent immediate hazards to the subject.
  1. Information may arise regarding the study which should be shared with previously enrolled subjects after the completion of a study, or a specific treatment or procedure. In this case, the information must be given to the research subjects.

Re-consenting Subjects Who Are Initially Consented by an LAR –